The Financial

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

The FINANCIAL — Roche on September 22 announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test ...
Yahoo

Roche’s test for Bordetella infections gains FDA clearance

Add Yahoo as a preferred source to see more of our stories on Google. Roche’s test is intended for diagnosing pertussis and other Bordetella infections. Credit: Hafizgnwn / Shutterstock.com.
Nasdaq

Roche's 4-in-1 Test For COVID, Flu, RSV Gets FDA Emergency Use Nod

(RTTNews) - Roche (RHHBY) said that the U.S. Food and Drug Administration has granted Emergency Use Authorization for its cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated ...
Modern Healthcare

FDA warns of potential false positive results with Roche Cobas rapid coronavirus, flu test

The US Food and Drug Administration released a letter on Friday warning clinical laboratory and point-of-care staff, as well as healthcare providers, that false positive results for Roche's test for ...
technologynetworks

Roche Receives FDA Clearance With CLIA Waiver for Its First Molecular Point-of-Care Test

Roche announced that its first point-of-care test for the detection of Bordetella infections, including whooping cough (pertussis), has been granted U.S. Food and Drug Administration (FDA) 510(k) ...